Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K090098 |
Device Name |
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON |
Applicant |
MAXIM HYGIENE PRODUCTS, INC. |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 01/15/2009 |
Decision Date | 01/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|